News
May 2025
Treatment efficacy and safety of adalimumab versus tocilizumab in patients with active and severe Takayasu arteritis: an open-label study
Summary
The management of Takayasu arteritis (TAK) remains challenging due to its relapsing nature, often requiring long-term therapy over years. Given the risks of refractory disease and glucocorticoid-related (GC) toxicity, safe and sustained GC-sparing strategies are essential. The 2021 ACR/VF guidelines currently favor tumor necrosis factor inhibitors (TNFi) over tocilizumab (TCZ) as initial therapy, based on greater clinical experience and supporting data [1]. However, direct comparative studies are lacking. By providing head-to-head efficacy and safety data on adalimumab (ADA) versus TCZ, the study aims to clarify which biologic agent may offer superior short-term and long-term benefits in patients with active and severe TAK [2].
This randomized, controlled, open-label study enrolled 40 patients who were treated with either ADA (n=21) or TCZ (n=19), both combined with GCs and methotrexate. The primary endpoint was the efficacy rate (ER) at 6 months, with secondary endpoints including ER at 9 and 12 months, relapse rate, GC tapering, adverse effects, and quality of life changes during treatment.
The results demonstrated that the ER at 6 months was significantly higher in the ADA group compared to TCZ in the intention-to-treat population (P=0.02), with a similar trend observed in the per-protocol analysis (P=0.06). By 9 and 12 months, efficacy rates were comparable between groups. The proportion of patients achieving glucocorticoid tapering to ≤10 mg/day at 6 months did not differ significantly (P=0.83). Relapse rates and adverse event frequencies over the 12-month follow-up were also similar (P=0.96 and P=0.55, respectively). For detailed statistics, see the following table.
Outcome |
Adalimumab (ADA) |
Tocilizumab (TCZ) |
P-value |
Patients enrolled |
21 |
19 |
|
ER at 6 months (ITT) |
85.71% (18/21) |
52.63% (10/19) |
0.02 |
ER at 6 months (Per-protocol) |
89.47% |
62.50% |
0.06 |
ER at 9 months |
61.90% (13/21) |
42.11% (8/19) |
0.21 |
CR rate at 9 months (ITT) |
47.62% (10/21) |
42.11% (8/19) |
0.73 |
CR & ER at 12 months |
57.14% (12/21) |
26.32% (5/19) |
0.05 |
Patients completing 12-month treatment |
12 |
8 |
|
GC dose ≤10 mg/day at 6 months |
47.37% |
43.75% |
0.83 |
Relapse Rate (12 months) |
9.52% |
10.53% |
0.96 |
Adverse Events (12 months) |
38.10% |
47.37% |
0.55 |
Impact on Patient Treatment and Future Perspectives
This study suggests that ADA, in combination with glucocorticoids and methotrexate, may offer superior short-term efficacy compared to TCZ in patients with active and severe TAK. These findings support the 2021 ACR/VF guideline recommendation favoring TNFi over TCZ as initial biologic to facilitate GC-sparing, reinforcing ADA’s role as a preferred first-line agent for remission induction. Nonetheless, the comparable long-term efficacy and safety profiles observed between ADA and TCZ indicate that TCZ remains a valid alternative, particularly for patients with intolerance or contraindications to TNFi.
References:
1. Maz M, Chung SA, Abril A, et al. 2021 American College of Rheumatology/Vasculitis Foundation Guideline for the Management of Giant Cell Arteritis and Takayasu Arteritis. Arthritis Care & Research. 2021;73(8):1071-1087. doi:10.1002/acr.24632.
2. Wang J, Kong X, Ma L, et al. Treatment Efficacy and Safety of Adalimumab Versus Tocilizumab in Patients With Active and Severe Takayasu Arteritis: An Open-Label Study. Rheumatology (Oxford, England). 2024;63(5):1359-1367. doi:10.1093/rheumatology/kead387.
Composed by
Dr. med. Andrea Gloor
Assistenzärztin, Universitätsklinik für Notfallmedizin
Inselspital, Universitätsspital Bern
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